MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Model Number	72203127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burrs were causing metal flaking during the procedure.A backup device was available to complete the procedure without any patient impact.There was a short delay reported.
Additional Manufacturer Narrative
Device investigation narrative - two 5.5 abrader burrs were returned for evaluation.Visual assessment of the devices show the inner burrs are dramatically bent, it appears the burrs were purposely bent.The inner burrs also show visible signs of material galling and debridement.The bushing is scored and there is corresponding debridement of the outer sheath.The condition of the devices indicate an excessive lateral load was placed on them during use.Per the devices ifu 1060595 ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.No root cause related to the manufacture of the device can be established.Further investigation is not warranted at this time.(b)(4).

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6836625
• Report Number: 1219602-2017-01058
• Device Sequence Number: 13830716
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)190930(10)50656379
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50656379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1